Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate

This is an open-label, randomized, 2-period crossover, inpatient study to be performed in healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will be administered after an overnight fast of at least 10 hours.

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Key information

Conditions

Healthy Subjects

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Men and women, aged 18 to 50 years. Women of non-childbearing potential may be included.
Body mass index in the range of 18 to 30 kg/meter squared and body weight equal to or greater than 50 kg.
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead electrocardiogram (graphic trace of the pattern of your heart beat).
Non-smoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history. Must abstain from smoking during inpatient stay.
Have a high probability for compliance with and completion of the study.

Treatment and study plan

pharmacokinetic (how the body absorbs and eliminates) interaction

Drug

Primary outcomes

To evaluate the effects of a single oral dose of AGG-523 on the pharmacokinetic profile of a single oral dose of tolbutamide in healthy subjects.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Randomized, Open Label, 2-Period Crossover Study to Determine the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate.

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Aug 29, 2006
Registry last updated: Aug 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed